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Doxercalciferol Before Surgery in Treating Localized Prostate Cancer

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: University of Wisconsin, Madison
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00022412
  Purpose

RATIONALE: Doxercalciferol may be an effective way to treat localized prostate cancer before surgery.

PURPOSE: Randomized phase II trial to study the effectiveness of giving doxercalciferol before surgery in treating patients who have localized prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: doxercalciferol
Procedure: conventional surgery
Phase II

MedlinePlus related topics:   Cancer    Prostate Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control
Official Title:   Phase II Open Label, Multi-Center Clinical Trial Of Modulation Of Intermediate Endpoint Biomarkers By 1x-Hydroxyvitamin D2 In Patients With Clinically Localized Prostate Cancer And High Grade PIN

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Intermediate endpoint biomarker modulation [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Study Start Date:   August 2001

Detailed Description:

OBJECTIVES:

  • Determine whether doxercalciferol modulates intermediate endpoint biomarkers in the development of prostate cancer in patients with localized prostate cancer.
  • Assess the toxicity of this drug in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 arms.

  • Arm I: Patients receive doxercalciferol once daily for 28 days. Patients then undergo prostatectomy.
  • Arm II: Patients undergo observation for 28 days. Patients then undergo prostatectomy.

PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study within 18 months.

  Eligibility
Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed localized adenocarcinoma of the prostate
  • Candidate for prostatectomy

PATIENT CHARACTERISTICS:

Age:

  • 21 and over

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 4,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.4 mg/dL
  • AST no greater than 3 times normal

Renal:

  • Creatinine no greater than 2.0 mg/dL
  • Calcium no greater than 10.2 mg/dL
  • No idiopathic urinary calcium stone disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • No prior hormonal therapy for prostate cancer
  • No concurrent hormonal therapy, including luteinizing hormone-releasing hormone agonists, antiandrogens, glucocorticoids, ketoconazole, finasteride, diethylstilbestrol, or progestins

Radiotherapy:

  • No prior brachytherapy or external beam radiotherapy for prostate cancer

Surgery:

  • See Disease Characteristics

Other:

  • At least 7 days since prior vitamin D therapy or calcium supplements
  • No other concurrent vitamin D analogues or calcium supplements
  • No concurrent magnesium-containing antacids
  • No concurrent thiazide-containing diuretics
  • No concurrent phenytoin, phenobarbital, glutethimide, digoxin, or digitalis
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022412

Locations
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa    
      Iowa City, Iowa, United States, 52242-1002
United States, New York
James P. Wilmot Cancer Center at University of Rochester Medical Center    
      Rochester, New York, United States, 14642
United States, Wisconsin
Medical College of Wisconsin Cancer Center    
      Milwaukee, Wisconsin, United States, 53226-3596
Veterans Affairs Medical Center - Madison    
      Madison, Wisconsin, United States, 53705
University of Wisconsin Comprehensive Cancer Center    
      Madison, Wisconsin, United States, 53792-6164
Meriter Hospital    
      Madison, Wisconsin, United States, 53715

Sponsors and Collaborators
University of Wisconsin, Madison
National Cancer Institute (NCI)

Investigators
Study Chair:     George Wilding, MD     University of Wisconsin, Madison    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000068813, WCCC-CO-99802, NCI-N01-CN-95130, WCCC-CO-2000169, NCI-P01-0188
First Received:   August 10, 2001
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00022412
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate  
stage I prostate cancer  
stage II prostate cancer  

Study placed in the following topic categories:
1 alpha-hydroxyergocalciferol
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms
Hydroxycholecalciferols

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Growth Substances
Vitamins
Physiological Effects of Drugs
Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008




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